Anteris Secures French Clearance for DurAVR Heart Valve Trial

Event summary

  • Anteris received regulatory clearance from France's ANSM for the DurAVR® Transcatheter Heart Valve global pivotal trial (PARADIGM Trial).
  • The trial will compare DurAVR® THV against commercially available TAVRs in approximately 1,000 patients.
  • Patient recruitment will commence at leading centers in France, a strategically important market.
  • The PARADIGM Trial aims to assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke, and cardiovascular hospitalization at one year post-procedure.

The big picture

Anteris' regulatory clearance in France is a critical step in its global clinical strategy, reinforcing the company's position in the transcatheter heart valve market. The PARADIGM Trial's success could potentially disrupt the current landscape dominated by established TAVR technologies, depending on the trial's outcomes and regulatory approvals in other regions.

What we're watching

Trial Execution
The pace at which patient recruitment and enrollment progresses in France and other regions will indicate the trial's feasibility and timeline.
Regulatory Strategy
Whether Anteris can secure additional regulatory clearances in other key markets to support the global expansion of the PARADIGM Trial.
Market Dynamics
How the outcomes of the PARADIGM Trial will position DurAVR® THV against existing TAVR technologies in the competitive transcatheter heart valve market.